An interventional study of Glyceryl Trinitrate and Placebo in Schizophrenia and Psychotic Disorders, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
This study evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed.
Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is integrated with the glutamate system. Glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO system, as glutamate receptors signal by way of NO.
Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry.
The primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →King's College London is the lead sponsor of 519 studies on the registry; 126 are open to participants now.
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Glyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total.
Drug: Glyceryl Trinitrate
The formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate.
Drug: Placebo
The emotionally salient version of the Jumping to Conclusions (JTC) task
Time frame: Change in performance from baseline to Day1, Day 2, Day 3, Day 7
The Hopkins Verbal Learning Task - Revised, immediate recall
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
Positive and negative syndrome scale (PANSS) (videotaped)
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
The Bond-Lader Visual Analog Scales
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
Plan to share: No
The record gives a start of Sep 2016, a primary completion of Apr 2019 and a completion of Apr 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitroglycerin